NCT06594900

Brief Summary

Healthy skeletal muscle development is crucial for a life-long quality of life. Childhood and puberty may be key periods for developing muscle growth and neuromuscular capacities, which are essential for bone-muscle interaction, metabolism, and participation in various sports. Even though the central role of physical activity in healthy physical development is well recognized, the decline in muscular fitness in today's children is alarming. This can lead to lasting deficits in muscle development and have a negative impact on overall health. Well-designed resistance training (RT) could address this problem, since it has an effective positive impact on muscular strength, bone density, metabolism, and spontaneous physical activity especially in childhood. In general, muscles adapt according to physical activity stimuli. However, children show different responses to exercise and training. The physiologic differences, which are reflected in lower neuromuscular capacities and hormonal responses, but also in a better resistance to fatigue than in adults, are not yet fully understood. It is well established, that RT in children is safe, effective and has multiple benefits for health. However, the underlying mechanisms that lead to increased muscle strength are unclear and it is unknown how sustainable these are. Today's common conception is that increased muscular strength is predominantly caused by neural adaptations and changes in muscle morphology due to lower androgenic responses are negligible. Although higher neuromuscular adaptation potential is evident, it is still not sufficient to explain all strength increases, suggesting that additional mechanisms are involved in the process. Most studies are outdated, had methodological and statistical limitations, and many state-of-the-art methods have not yet been applied to children, hence, there is a need for a comprehensive, in-depth investigation to understand muscle adaptations to training and growth in children. With this better understanding of the impact and adaption to RT stimuli on neuromuscular and structural development the proposed project can serve as a foundation for more targeted prevention strategies. The aim of this study is to investigate neuromuscular, hormonal, and morphological adaptations following 4 and 20 weeks of RT, while also examining their longitudinal retention through two consecutive follow-ups over 1.5 years. In this randomized controlled trial, state-of-the-art measurement methods are employed to accurately delve into mechanisms of adaptation, some of which have not yet used in children before due to limited time or infrastructure resources. The neuromuscular assessments include maximal and explosive strength of leg extensors, voluntary activation, motor unit decomposition, as well as central and peripheral neuromuscular fatigability. The hormonal changes are measured acutely (testosterone, cortisol, IGF-1 and growth hormone) and chronically (testosterone, progesterone and IGF-1) in response to one or several training sessions. Static and dynamic ultrasound imagining is used to quantify muscle size, fascicle shortening velocity and muscle architecture. This design allows in-depth insights into short- and long-term adaptations on several physiological levels to provide a novel mechanistic understanding of muscle growth and function in children. The major innovation of this research is the integration of diverse scientific perspectives, combining insights from neuromuscular physiology, endocrinology, and muscle morphology to provide a holistic understanding of RT adaptations and development in children of both sexes. This comprehensive approach can form the basis for future training programs, enabling next generations to better understand the potential impact of musculature on health.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Nov 2024Dec 2027

First Submitted

Initial submission to the registry

September 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 19, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

March 5, 2025

Status Verified

September 1, 2024

Enrollment Period

2.8 years

First QC Date

September 10, 2024

Last Update Submit

March 4, 2025

Conditions

Keywords

resistance trainingstrength trainingchildrenprepubertal childrenhealthneuromuscular capacitiesneurmusculardevelopmentcrossfitfunctional trainingweigth trainingneuromuscular adaptationhormonal adaptationstructural adaptationmorphological adaptationchildren developmentphysiological adaptation

Outcome Measures

Primary Outcomes (1)

  • maximal isometric voluntary contraction of knee extensor muscles

    Maximal isometric voluntary contraction (MVC) of knee extensor muscles refers to the level of maximal force, which can be transferred to a resisted dynamometer. It is highly adaptive from stimuli like training through mainly two pathway: by neuromuscular adaptation or muscle hypertrophy. Therefore, this is a sensitive measure during growth and resistance training intervention. The measurement of isometric MVC of knee extensor muscles will be performed in a seated position in a dynamometer (Isomed 2000, D. \& R. Ferstl GmbH, Germany). The test subjects are fixed at a hip and knee angle of 120° and 60° respectively. According to Maffiuletti et al. (2016) the subjects are instructed to extend their legs as fast and forceful as possible and hold the contraction for 3-5s against lever arm of the dynamometer. After a familiarization attempt, the measurement is performed 2-5 times (until \<5% difference between two trials) with a rest of 1 min in between. Peak torque will be used as outcome.

    From enrollment (PRE) to after 4 weeks of intervention (MID), to the end of Intervention (POST), as well as to the two Follow-ups after 9 month each.

Secondary Outcomes (7)

  • Neuromuscular fatiguability

    From enrollment (PRE) to after 4 weeks of intervention (MID), to the end of Intervention (POST), as well as to the two Follow-ups after 9 month each.

  • Power and explosive force

    From enrollment (PRE) to after 4 weeks of intervention (MID), to the end of Intervention (POST), as well as to the two Follow-ups after 9 month each.

  • Voluntary activation

    From enrollment (PRE) to after 4 weeks of intervention (MID), to the end of Intervention (POST), as well as to the two Follow-ups after 9 month each.

  • Muscle size

    From enrollment (PRE) to after 4 weeks of intervention (MID), to the end of Intervention (POST), as well as to the two Follow-ups after 9 month each.

  • Motor unit activity

    From enrollment (PRE) to after 4 weeks of intervention (MID), to the end of Intervention (POST), as well as to the two Follow-ups after 9 month each.

  • +2 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

This group receives no training programme and just continues its life and physical activity as it used to do.

Resistance training intervention

EXPERIMENTAL

The participants in the intervention group take part in a 20-week strength training programme in which they train twice a week for 60 min. The training programme focuses on strengthening the knee extensor muscles. Each training session consists of three phases: Warm-up, resistance training and coordination exercises. In the warm-up as well as coordination phase, full-body games are played to activate and challenge the children. The strength training phase forms the core of each session and includes exercises such as squats, lunges and step-ups. These exercises are performed in four sets of 8-12 repetitions, with the intensity being increased over time. The aim is to perform the exercises with great effort, but not to the point of complete exhaustion.

Behavioral: resistance training intervention

Interventions

The RT intervention focuses on knee extensor muscles, following current guidelines. Children will attend two supervised 1-hour sessions per week, proven sufficient for adaptations. Trained coaches and a scientific assistant, supported by master students, will document the sessions. Sessions are spaced 48 hours apart, totaling 40 over 20 weeks, with eight sessions between PRE and MID. Each session has three phases: warm-up, strength, and coordination. Warm-up involves whole-body games to increase heart rate and prepare for strength training. The strength phase, documented for effort and adjustments, includes squats, lunges, and step-ups, with intensity changes over time. Four sets of 8-12 repetitions per exercise are performed, aiming for strength increase and hypertrophy. Movements are done with great effort but not until voluntary failure. The coordination phase focuses on age-appropriate strength and motor skills through a circuit of challenges.

Also known as: strength training, functional training, crossFit training
Resistance training intervention

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Able to travel 6 times to the Departement of Sports, Exercise and Health for the measurements
  • Able to travel 2 times per week to CrossFit Basel GmbH for 20 weeks to participate on the training
  • Able to verbally communicate pain or discomfort
  • Signed informed consent information from the parents

You may not qualify if:

  • Any acute or chronic medical condition
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
  • Regular participation in resistance training (incl. CrossFit®) in the previous year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Sport, Exercise and Health

Basel, Basellandschaft, 4052, Switzerland

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 10, 2024

First Posted

September 19, 2024

Study Start

November 19, 2024

Primary Completion (Estimated)

September 15, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

March 5, 2025

Record last verified: 2024-09

Locations